23andMe Resumes Genetic Testing

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A few years ago, the Food and Drug Administration (FDA) required 23andMe to stop selling their DNA test kits to consumers. The FDA objected to the health related results. Recently, 23andMe obtained FDA approval to begin offering genetic testing again.

In October of 2015, 23andMe announced a new experience for their customers. The company is now able to offer the first and only direct-to-consumer genetic testing service that meets United States FDA standards. New customers can expect to receive the results from 23andMe’s DNA test kits within six to eight weeks of returning their samples to the lab.

The same announcement notes that 23andMe invested nearly two years of work conducting extensive user testing, working with regulators, scientists, physicians, and top product design experts. This effort is what helped them to obtain FDA approval. Some of the new things offered in 23andMe’s updated DNA testing kits include: new carrier status reports, wellness reports, information about traits and ancestry, and updated tools a consumer can use to explore more aspects of their own genetic information.

There is something to be aware of in regards to the carrier status reports. A disclaimer says: “Our tests can be used to determine carrier status in adults from saliva collected using an FDA-cleared collection service (Oragene DX model OGD.500.001), but cannot determine if you have two copies of the genetic variant. Each test is most relevant for people of certain ethnicities. The tests are not intended to diagnose a disease, or tell you anything about your risk for developing a disease in the future. On their own, carrier status tests are not intended to tell you anything about the health of your fetus, or your newborn child’s risk of developing a particular disease later in life.”

Judging from the comments left on the 23andMe announcement post, it appears that the biggest complaint consumer are having about the new DNA test kits is the price. The old test kits cost $99. The new ones are being sold for $199.00. This is upsetting to some potential consumers.

Are you a current customer of 23andMe? According to their announcement, 23andMe is trying to transition their existing customers to the new experience as quickly as possible. The going appears to be slow and is dependent on validation and local requirements.

CBS News reports that the FDA has granted 23andMe permission to test for 36 autosomal recessive disorders that can be genetically passed from a parent to his or her offspring. Two of those tests are for sickle cell anemia and for cystic fibrosis.